Your session is about to expire
← Back to Search
Epidiolex for Tuberous Sclerosis Complex (EpiCom Trial)
Phase 4
Recruiting
Research Sponsored by Jazz Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 4, week 13, week 26, week 52
Awards & highlights
EpiCom Trial Summary
This trial will look at how a new treatment affects people aged 1-65 with a disease called tuberous sclerosis complex (TSC) who have seizures.
Who is the study for?
This trial is for individuals aged 1 to 65 with tuberous sclerosis complex (TSC) who have seizures. Participants must be on stable anti-seizure medication, not have used CBD-OS recently, and agree to consistent contraceptive use if applicable. They cannot join if they've had certain medical conditions or treatments that could affect the study, or a history of substance abuse.Check my eligibility
What is being tested?
The study tests Epidiolex (Cannabidiol Oral Solution) as an additional treatment for TSC-related seizures and behavioral issues. It aims to see how adding this solution affects patients' behavior and other related outcomes alongside their current seizure medications.See study design
What are the potential side effects?
Epidiolex may cause side effects such as sleepiness, decreased appetite, diarrhea, fever, vomiting, fatigue. More serious but less common effects include thoughts of suicide or liver problems.
EpiCom Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 4, week 13, week 26, week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 4, week 13, week 26, week 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Aberrant Behavior Checklist (ABC) score
Change in Adult Behavior Checklist (ABCL) score
Change in Adult Self-Report (ASR) score
+23 moreSide effects data
From 2015 Phase 3 trial • 120 Patients • NCT0209137531%
Diarrhoea
31%
Somnolence
26%
Decreased appetite
18%
Fatigue
15%
Vomiting
15%
Pyrexia
11%
Upper respiratory tract infection
11%
Lethargy
8%
Convulsion
7%
Weight decreased
7%
Gamma-glutamyltransferase increased
7%
Irritability
7%
Cough
7%
Transaminases increased
5%
Status epilepticus
5%
Nasopharyngitis
2%
Pneumonia
2%
Oral herpes
2%
Platelet count
2%
Abdominal distension
2%
Abdominal pain
2%
Gastrointestinal haemorrhage
2%
Asthenia
2%
Lower respiratory tract infection
2%
Gamma-glutamyltransferase
2%
Hypophagia
2%
Hypotonia
2%
Myoclonus
2%
Respiratory failure
2%
Epistaxis
2%
Hypovolaemic shock
2%
Aspartate aminotransferase increased
2%
Liver function test abnormal
2%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
GWP42003-P 20 mg/kg/Day Dose
EpiCom Trial Design
1Treatment groups
Experimental Treatment
Group I: Cannabidiol Oral SolutionExperimental Treatment1 Intervention
Participants who will receive the Cannabidiol Oral Solution (CBD-OS) titrated up to a dose of 12.5 mg/kg administered twice daily for a total dose of up to 25 mg/kg/day for 26 consecutive weeks. Participants will have the option to continue receiving the CBD-OS for an additional 26 weeks, for a total of 52 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabidiol Oral Solution [Epidiolex]
2020
Completed Phase 3
~20
Find a Location
Who is running the clinical trial?
Jazz PharmaceuticalsLead Sponsor
248 Previous Clinical Trials
34,169 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a serious health condition that is not epilepsy.I started taking felbamate less than a year ago.I haven't been sick with anything other than epilepsy in the last 4 weeks.My tumor growth is related to my TSC condition.My liver is not working well.I am within the age range required for this study.I have been diagnosed with TSC and have a history of seizures.I have never taken CBD-OS treatment or stopped it at least 3 months ago.I am either male or female.I am a man and will use birth control and not donate semen during the study.I am not pregnant or breastfeeding and follow specific birth control guidelines.My epilepsy treatment has been the same for the last 4 weeks.I have been on a stable dose of seizure medication for at least 4 weeks.I had major epilepsy surgery that could affect outcome assessments.
Research Study Groups:
This trial has the following groups:- Group 1: Cannabidiol Oral Solution
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the geographic scope of this research endeavor?
"This medical trial is at present recruiting from 7 different sites, which include Roseville, Winston-Salem and Cincinnati. It's important to select the most proximate location in order to minimize any travelling associated with participation."
Answered by AI
Who has the eligibility to join this investigation?
"To be enrolled in this trial, prospective participants must have tuberous sclerosis complex neuropsychiatric disorder and fall within the age range of one year to 65 years old. The number of enrollees required is 75 individuals."
Answered by AI
Is Cannabidiol Oral Solution considered a risky medication for human consumption?
"Extensive clinical data confirms the safety of Cannabidiol Oral Solution, leading to a score of 3. This medication is approved and currently in Phase 4 trials."
Answered by AI
Are enrollment slots still available in this clinical trial?
"At the current moment, this clinical trial is not recruiting patients. The study was posted on June 1st 2023 and its most recent update came in May 9th of the same year according to data hosted on clinicaltrials.gov. While signups for this experiment are closed at present, there are 491 other experiments with open recruitment opportunities available now."
Answered by AI
Is it permissible for individuals under the age of 35 to participate in this experiment?
"This medical research project's selection criteria requires participants to be between one and sixty-five years of age. There are 41 trials for people younger than 18, while 354 studies have been designed for individuals over 65."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger